Une étude de Phase 1b de Talimogène Laherparepvec en combinaison avec Atezolizumab chez les patients présentant un cancer du sein métastatique triple négatif et un cancer colorectal avec métastases hépatiques.

Biological: Talimogene Laherparepvec;Biological: Atezolizumab

Gender: All
Maximum age: 99 Years
Minimum age: 18 Years

Inclusion Criteria:

- Criteria1, Participant provided informed consent prior to any study-specific
activities/procedures.

- Criteria 2, Confirmation of triple negative breast cancer or colorectal cancer with
liver metastases by laboratory testing.

- Criteria 3, Subjects with triple negative breast cancer with liver metastases, or
subjects with colorectal cancer with liver metastases are eligible if they have had
disease progression during or after one or more prior standard of care systemic
anti-cancer therapy (eg,chemotherapy, targeted therapy) for metastatic disease or if
they progress during or within 6 months of receiving adjuvant therapy. If subjects, in
the opinion of the investigator, are deemed not appropriate candidates for systemic
anti-cancer therapy for metastatic disease or if they refuse systemic anti-cancer
therapy for metastatic disease, they may be eligible after investigator discussion
with Sponsor medical monitor for approval.

- Criteria 4, Participants have measurable disease which is equal to one or more
metastatic liver lesions that can be accurately and serially measured that are greater
than or equal to 1 cm dimension and for which the longest diameter is greater or equal
to 1 cm as measured by CT (Computed Tomography) scan or magnetic resonance imaging.
The metastatic liver lesion(s) must not be in an area that received prior localized
therapies.

- Criteria 5, Metastatic liver lesions for injection must be without necrosis (dead
tissue )and must be be located where any tumor swelling will not lead to gall bladder
tract obstruction or lead to bleeding risk.

- Criteria 6, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.

- Criteria 7, Life expectancy greater than or equal to 5 months.

- Criteria 8, Adequate organ function within 4 weeks prior to enrollment. This includes
hematology, renal, hepatic and blood-clotting functions as defined by protocol.

- Criteria 9, Female subjects of childbearing potential should have a negative serum
pregnancy test within 1 week prior to enrollment.

- Criteria 10, Other Inclusion Criteria May Apply.

Exclusion criteria:

- Criteria 1, Participant is a candidate for hepatic surgery or local regional therapy
of liver metastases with curative intent.

- Criteria 2, More than one third of the liver is estimated to be involved with
metastases.

- Criteria 3, There is invasion by cancer into the main blood vessels such as the portal
vein, hepatic vein or the vena cava.

- Criteria 4, Participant is currently receiving or has received liver
metastatic-directed therapy ( eg: radiation, ablation, embolization) less than 4 wks
prior to enrollment or hepatic surgery.

- Criteria 5, History of other malignancy within the past 5 years prior to enrollment
with some exceptions, as outlined in the protocol.

- Criteria 6, Active or untreated central nervous system (CNS) metastases per CT or
magnetic resonance imagine (MRI) evaluation during screening.

- Participants with a history of CNS metastases are eligible provided they are stable
and meet the criteria details in the protocol.

- Criteria 7, Other Medical Conditions as noted in the protocol.

- Criteria 8, Other Exclusion Criteria May Apply.